The Tobacco Diaries: Lessons Learned and Applied to Regulation of Dietary Supplements

Joanna K. Sax

Little is known about adverse reactions to dietary supplements because these events are underreported. The Food and Drug Administration’s (“FDA”) ability to regulate dietary supplements has a long and complicated history, and the battle over regulation continues. On a simple level, the debate over regulation of dietary supplements boils down to the FDA’s charge to protect the public from harmful drugs and devices versus manufacturers’ desire not to be regulated and individuals’ autonomy to make decisions about what supplements to take. The arguments surrounding this debate are reminiscent of the debates surrounding the regulation of tobacco. The tobacco companies fought hard to keep the FDA out of regulating cigarettes; some members of the public argued that they should be allowed to take personal responsibility over the choice to use tobacco; and the FDA fought to bring tobacco within its regulatory authority.